Load-controlled device for a patterned skin incision

ABSTRACT

A skin incision device has a casing having a bottom surface with a slot formed therein, a cover positioned on the casing and slidable in a direction toward the bottom surface, a blade positioned in the casing adjacent the slot, an actuator cooperatively positioned between the cover and an interior of the casing, and a carriage element. The actuator engages the blade by its horizontal displacement triggered by the slidable movement of the cover toward the bottom surface of the casing. The carriage element guides the movement of the blade between a pre-actuated position and a post-actuated position. The blade moves outwardly through the slot, cuts with a horizontal movement, and returns inwardly through the slot.

RELATED U.S. APPLICATIONS

The present application is a continuation-in-part application claimingpriority from U.S. patent application Ser. No. 10/628,199, filed on Jul.28, 2003, and entitled “LOAD-CONTROLLED AUTO-ACTUATED SKIN INCISIONDEVICE”, presently pending.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

FIELD OF THE INVENTION

The present invention relates to medical devices. More particularly, thepresent invention relates to devices for incising the skin. Inparticular, the present invention relates to internal actuators for skinincising devices which apply a controlled load and a constant forceduring the incising operation for a patterned incision. Additionally,the present invention relates to skin incising devices that are used forthe purpose of blood acquisition.

BACKGROUND OF THE INVENTION

In the medical field, it is a very common procedure, and often verynecessary, to conduct a bleeding time test which measures the timerequired for the cessation of bleeding following a skin incision. Thistest is medically important because extended or prolonged bleeding timecan be associated with, for example, a lack of or a great excess ofplatelets, abnormality of platelet function, coating of platelets byspecific proteins or foreign materials or the action of certain drugs;e.g., aspirin.

Although the bleeding time test procedure was first describedapproximately ninety years ago, it did not receive general acceptanceuntil the 1940's at which time the test's sensitivity was increased bymaking a skin incision on the forearm of the patient while maintaining ablood pressure cuff inflation to maintain venostasis at a standardizedlevel. Using this procedure, a technologist simultaneously starts astopwatch while making the incision. The emerging blood is then gentlyblotted every thirty seconds. The cessation of bleeding is defined asthe time at which the blotting paper is no longer stained by theemerging blood. This amount of time is generally recorded to the nearesthalf minute.

Disposable bleeding time devices were first introduced in 1978 tofacilitate automation and convenience. These devices improved theacceptance of the test by both the patient and the operator. However,the results were still subject to a variety of technical variables.Additionally, these devices were significantly more expensive thanprevious methods. This hindered the acceptance of such devices in manycountries around the world. Importantly, different disposable devicesevolved over time which were functionally quite dissimilar so that theresults were not comparable. Thus, standardization remained an elusivegoal in bleeding time testing.

An important bleeding time testing device is known as the TRIPLETT™bleeding time testing device. This was named after the noted physicianin blood coagulation and hematopathology, Dr. Douglas Triplett. Thisdevice is presently manufactured and sold by Helena Laboratories ofBeaumont, Tex. This device met the goal of global standardization inbleeding time testing and utilizes advanced technology at a universallyaffordable price. This was a product that provided a new level of valueto automated, disposable bleeding time devices. This TRIPLETT™ bleedingtime testing device was designed to be user and patient friendly,virtually painless, and to mimic the incision motion of the originalbleeding time method. The device makes a standardized surgical incisionone millimeter deep by five millimeters long for accurate sensitivebleeding time testing. The blade automatically retracts after incisionsso as to ensure safety. The device includes a large contact surface thatdistributes the downward force over a wider area of skin so as to reducethe potential for deep non-standardized cuts. This device is presentlysubject to patent protection under U.S. Pat. Nos. 5,662,672 and5,733,300.

In the past, various U.S. patents have issued in association withdevices for creating incisions in skin. There is a wide variety ofinventions specifically geared toward creation of skin incisions for usein the medical field for blood sampling and bleeding time testing. U.S.Pat. No. 4,535,769, issued on Aug. 20, 1985 to Burns, discloses anautomatic retractable lancet assembly that includes a housing with asharp-pointed lancet movably mounted therein. A depressible plunger andslide mechanism actuates the movement of the lancet outwardly from thehousing, which is an elongate cylinder.

U.S. Pat. No. 5,527,333, issued on Jun. 18, 1996 to Nikkels et al.,presents a disposable blood sampling device for a precise incision ofpredetermined length and depth in the skin of a patient. A trigger isslidably disposed in the opening in the top surface of the device, whichis generally cylindrical in shape. A single spring, only, is extended bythe trigger when the device is actuated.

U.S. Pat. No. 5,529,581, issued on Jun. 25, 1996 to Cusack, also teachesa lancet device and associated method used for obtaining a blood samplefrom a patient. A slotted aperture is formed through a safety housing inthe region of the housing placed against the skin. An invertible springmember is a curved structure that automatically inverts into a generallyoppositely curved orientation when the invertible spring member isflattened by a predetermined degree. U.S. Pat. No. 5,797,940, issued onAug. 25, 1998 to Mawhirt et al., describes a device for making anadjustably sized incision in skin. The device comprises a housing havinga slotted opening; a blade; a triggering mechanism and an incision sizeadjusting mechanism associated with the housing for selectivelyadjusting the size of the incision.

U.S. Pat. No. 5,395,388, issued on Mar. 7, 1995 to Schraga, describes asingle use disposable lancet device including a generally cylindricalhousing wherein a spring is contained, the spring including a first endfixed within the housing and having a movable second end zone with apointed blade or terminal end, the second end zone being movablerelative to a normal position with the pointed terminal end containedwithin the housing and adjacent a first opening in the housing.

A study of the prior art also reveals a number of low-cost devices forcreating incisions in skin. For example, U.S. Pat. No. 5,851,215, issuedon Dec. 22, 1998 to Mawhirt et al., teaches a low-cost safety lancet forcreating a skin incision. The lancet contains a unitarily formed plasticbody, thereby making the lancet device easy to manufacture at a lowcost. The lancet device includes a blade beam having a cutting bladedisposed at one end for generating an incision in a patient's skin. U.S.Pat. No. 5,584,846, issued on Dec. 17, 1996 to Mawhirt et al., presentsanother low-cost safety lancet for creating a skin incision. The lancetcontains a unitarily formed plastic body, containing a resilient springloop that attaches an arm element to an opposing base element. A bladeis disposed on the arm element.

Finally, a number of U.S. patents have issued in this field of art usingan enclosed spring structure. For example, U.S. Pat. No. 4,064,871,issued on Dec. 27, 1977 to W. J. Reno, teaches a bleeding time testingdevice that includes a housing having a surface with a slot defining alongitudinal opening into the housing. A blade is mounted within thehousing for movement of the blade tip through and along the slot.Biasing springs are provided within the housing to urge the bladethrough the slot a predetermined distance and along the slot for apredetermined length to control the depth and length of an incisionproduced with the device. A trigger is provided to initiate movement ofthe blade along with a safety pin to prevent the inadvertent activationof the device.

U.S. Pat. No. 5,314,441, issued on May 24, 1994 to Cusack et al.,presents a lancet device with a blade support arm pivotably securedwithin a hollow housing. The pivot connection between the blade supportarm and the housing is formed by a pivot pin, which is free toreciprocally move within the slot receptacle. The rotation of the bladesupport arm about the pivot pin is implemented by a bias spring. Theblade of the device implements an incision and is again retracted intothe housing traversing a “tear drop” shaped path.

U.S. Pat. No. 6,221,089, issued on Apr. 24, 2001 to Mawhirt et al.,teaches a device for making an incision in skin, having a housing with aslotted opening, and a triggering mechanism disposed within the housingfor propelling a blade coupled thereto, through the slotted opening ofthe housing to make an incision in the skin. The triggering mechanismincludes a finger engageable trigger located external to the housing foractuating the triggering mechanism and a spring anchoring assembly forautomated machine arming the device after the triggering mechanism hasbeen assembled into the housing.

One of the problems associated with the use of the TRIPLETT™ device isthat the force applied to actuate the device is off-center from thelocation at which the blade emerges from the cutting surface. As such,variations of pressures applied to the device can occur. As a result,the bleeding time testing can have a lack of consistent testing. Angulardeflections of the cutting surface can also occur by the off-centerapplication of pressure to the actuator of such cutting device. As such,a need has developed for a device for actuating such blood acquisitiondevices such that the pressure of actuation will be directly above thelocation of the incision.

U.S. Provisional Application Ser. No. 60/393,971, filed on Jul. 25,2002, by the present applicant, describes a constant force actuator fora blood acquisition device. This constant force actuator is externallyapplied to an existing blood acquisition device. The blood acquisitiondevice includes a body having a bottom surface from which a cuttingblade can emerge so as to carry out an incision. The body includes aswitch pin actuator that extends outwardly of the top surface in theacquisition device body. The switch pin is movable between apre-actuating position and an actuating position. A safety tab isremovably positioned between the switch pin actuator so as to retain theswitch pin actuator in its pre-actuating position. The safety tab is tobe removable so as to enable the testing device to be actuated by movingthe switch pin from the pre-actuating position to the actuatingposition. The cutting blade is cooperative with the switch pin actuatorto move outwardly of the bottom surface of the body of the testingdevice when the switch pin is moved to the actuating position.

In this provisional patent application, a constant force device ismechanically attached to the surface of the body of the bloodacquisition device. The constant force device has a housing that ismounted onto the top surface of the blood acquisition device so as toextend parallel to the bottom surface of the device. A suitable springclip is provided on the housing so as to allow the actuator housing tobe affixed to the body of the blood acquisition device. A slide frame ismounted on the housing so as to be in slidable relationship to thehousing. The slide frame is movable between a pre-activated position toan activated position. In the pre-activated position, the slide framehas a surface which resides against the switch pin actuator in thepre-activated position. A spring is mounted so as to be cooperative withthe slide frame so as to urge the slide frame to the actuated position.An actuator button is slidably mounted on the housing so as to beslidable in a direction transverse to the plane of the bottom surface ofthe blood acquisition device. When the actuator button is depressed, thespring associated with the slide frame urges the slide frame in ahorizontal direction parallel to the bottom surface of the bloodacquisition device and thereby moves the switch pin actuator from thepre-actuating position to the actuating position. The actuator button ispositioned directly above the center line of the cutting blade duringthe incision procedure.

It is an object of the present invention to provide a skin incisiondevice that will not make the incision until a controlled vertical forceis applied against the subject tissue.

It is another object of the present invention to provide a skin incisiondevice that removes the variations of force that are applied bydifferent operators at the time the incision is performed.

It is another object of the present invention to provide a skin incisiondevice which allows the actuation force to be easily altered by amodification of an actuator means for the purpose of requiring differentactuating forces to be provided.

It is a further object of the present invention to provide a skinincision device which can be assembled with no force required to loadthe components which interact to produce the incision.

It is a further object of the present invention to provide a skinincision device in which the blade is propelled by a designed controlledinteraction of internal components which creates a slicing into, acrossand slicing out of subject tissue for the purpose of minimizing thetrauma to the subject tissue.

It is a further object of the present invention to provide a skinincision device in which a consistent patterned incision can be made bythe blade.

It is another object of the present invention to provide a skin incisiondevice which reduces the introduction of undesirable components of theskin tissue into the incision area and blood sample.

It is still a further object of the present invention to provide a skinincision device that promotes rapid healing of the incision location.

It is still another object of the present invention to provide a skinincision device which has a concurrent action at the incision whichlocks the device and prohibits the ability of the device to be reloadedfor additional uses.

It is a further object of the present invention to provide a devicewhich is easy to use, relatively inexpensive and easy to manufacture.

These and other objections of the present invention will become apparentfrom a reading of the attached specification and appended claims.

BRIEF SUMMARY OF THE INVENTION

The present invention is a skin incision device that has a casing with aslot formed at a bottom surface thereof, a cover positioned on thecasing and slidable in a direction transverse to a plane of the bottomsurface of the casing, a blade pivotally positioned within the casinggenerally adjacent the slot, an actuator positioned within the casing,and a carriage anchored within the casing and pivotally attached to theblade. The actuator is actuatable by slidable movement of the covertoward the bottom surface of the casing and converts transverse movementof the cover into horizontal movement of the actuator. The horizontalmovement of the actuator causes the actuator to engage the blade at apre-actuated position through a post-actuated position such that atleast a portion of the blade extends outwardly of the slot during themovement between the pre-actuated position and the post-actuatedposition. The carriage guides movement of the blade from thepre-actuated position through the post-actuated position.

In the present invention, the casing has a generally open end oppositethe bottom surface and sides extending upwardly from the bottom surfaceand a top surface extending over the open end and over at least aportion of the sides of the casing. At least of one the sides of thecasing has a barb extending outwardly therefrom. The cover has a wallextending over a portion of the side of the casing. The wall has a firstretaining slot formed therein and a second retaining slot formed thereinabove the first retaining slot. The barb engages the first retainingslot when the blade is in the pre-actuated position. The barb engagesthe second retaining slot when the blade is in the post-actuatedposition.

The casing is further comprised of a release seat, a guide member, acapture seat and a lock member made integral with an inner surface ofthe casing. The release seat houses the actuator when the blade is inthe pre-actuated position. The guide member has a bottom edge slidablycontacting the carriage when the blade moves from the pre-actuatedposition to the post-actuated position. The capture seat retains theactuator at the post-actuated position. The lock member holds theactuator in the capture seat. The casing may be comprised of twoportions that are joined together. One of the portions has an interiorsurface facing the interior surface of the other of the portions.

The blade of the present invention includes a razor member having acutting edge, a retaining hole positioned on an end of the blade and anelongated hole positioned adjacent an opposite end of the blade. Theelongated hole is rotatable relative to the casing. The carriage iscooperatively connected to the retaining hole so as to pivotally guidethe razor member between the pre-actuated position and the post-actuatedposition. The casing has a blade retainer peg formed therein adjacentthe slot of the casing such that the elongated hole of the blade ispositioned on the blade retainer peg.

The blade can have a first pivot point interconnected to the casing anda second pivot point attached to the carriage. The first pivot point isin cam-relation/rotatable on the casing during movement of the bladefrom the pre-actuated position to the post-actuated position. The firstpivot point of the blade can be an obround formed therein. This obroundcam be positioned over a blade retainer peg of the casing.

In the present invention, the actuator includes a top edge, a resilientcurved member extending downwardly from the top edge, and a knucklepositioned on a terminal end of the curved member. The top edge is inabutment with the inner surface of the cover during movement of theblade from the pre-actuated position to the post-actuated position. Theknuckle is retained in position by the release seat when the blade is inthe pre-actuated position and engages the blade during movement of theblade from the pre-actuated position to the post-actuated position. Thecasing retains the knuckle in the post-actuated position in the captureseat of the casing. Optionally, a lock member is used to preventre-loading the actuator such that the present invention is a one-useapplicator.

The carriage comprises an anchored end positioned in the casing, anarcuate member extending from the anchored end, and a cam positioned ona terminal end of a arcuate member and pivotally attached to the blade.The cam guides the movement of the blade outwardly from the slot andfrom the pre-actuated position and causes a horizontal movement of theblade after the outward movement, and guides another movement of theblade inwardly toward the slot and to the post-actuated position. Thecam has a curved shape rotatable around a pivot point attached to theblade.

In general, the present invention is a device for making a standardincision in skin tissue for the purpose of blood acquisition. Thepresent invention is a single-use/disposable device which includes theslot for the purpose of allowing the blade to travel out of the deviceto form the incision and then retracting back into the housing of thedevice. The movable cover travels in a downward motion so as to apply aconstant pressure against the skin during actuation of the blade. Theknuckle of the actuator will release from the release seat and contactthe blade when a controlled load limit is achieved. When a controlledload limit is achieved, downward pressure of the cover is converted bythe actuator into horizontal movement of the knuckle at an end of theactuator. The horizontal motion of the knuckle engages the blade at thepre-actuated position. As the knuckle moves horizontally, the blade ismoved from the pre-actuated position to the post-actuated position. Thecarriage guides the blade during movement by the cam pivotally attachedto the blade. The interaction of the surfaces of the cam against theguide member of the casing propels the razor member out of the housing,through the skin, and back into the housing in a very controlled action.This controlled action of the razor member is such the razor member isslicing upon entry into the skin, guided horizontally while at depth,and slicing upon exiting the skin. This action of slicing, both enteringand exiting, will minimize the trauma to the skin, will reduce theintroduction of undesirable elements of the skin tissue into theincision and blood sample, and will promote the rapid healing of theincision location.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an outer perspective view of the skin incision device of thepresent invention.

FIG. 2 is an exploded perspective view of the skin incision deviceshowing the cover and the casing.

FIG. 3 is an interior elevation view of the interior structure of skinincision device of the present invention as shown in its pre-actuatedposition. The blade and cover are shown in broken lines.

FIG. 4 is an interior elevation view of the interior structure of theskin incision device of the present invention showing the device in itsmovement between the pre-actuated position and the post-actuatedposition. The blade and cover are shown in broken lines.

FIG. 5 is an interior elevation view of the interior structure of theskin incision device of the present invention showing the device in itspost-actuated position within the first panel. The blade and cover areshown in broken lines. The knuckle rests in the knuckle travel pocket onthe second panel in the post-actuated position (position in second panelnot shown for post-actuated stage).

FIG. 6 is another interior elevation view of interior structure of theskin incision device of the present invention showing another panel ofthe casing shown in FIGS. 3–5. The blade and cover are shown in brokenlines.

FIG. 7 is a partial enlarged perspective view of the cam of the carriageof the skin incision device of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, there is shown the skin incision device 10in accordance with the teachings of the preferred embodiment of thepresent invention. The skin incision device 10 includes a casing 12having a bottom surface 14 and a cover 16 slidably positioned on thecasing 12. The top cover 16 is slidable in a direction transverse to aplane of the bottom surface 14. The casing 12 can have a first panel 9and a second panel 11.

The casing 12 has a generally open end 18 opposite the bottom surface14. The casing 12 has sides 20 and 22 extending upwardly from the bottomsurface 14. The cover 16 extends over the open end 18 of the casing 12and has a wall 24 extending over at least a portion of the side 20 ofthe casing 12. The side 20 has a barb 26 extending outwardly therefrom.The wall 24 has a first retaining slot 28 and second retaining slot 30formed above the first retaining slot 28. As can be seen in FIG. 1, thebarb 26 engages the first retaining slot 28.

In FIG. 1, the device 10 is shown in its pre-actuated position.Ultimately, the bottom surface 14 will be placed upon the surface of theskin and the cover 16 will be pressed downwardly toward the bottomsurface 14. As a result, the barb 26 will free itself from the firstretaining slot 28. When the device 10 has incised the skin and the bladeis retained in its post-actuated position, the barb 26 will then beretained within the second retaining slot 30. As a result, the barb 26prevents reuse of the device 10. Within the concept of the presentinvention and as shown in FIGS. 3–5, it is important to note thatanother barb 42 can also be placed on the opposite side 22 of casing 12so as to suitably engage corresponding first retaining slot 37 andsecond retaining slot 39 formed on the opposite wall 34 of the cover 16.

In FIGS. 1 and 2, the cover 16 is also shown with triangularly shapedprotrusions 32 that can be used for gripping the device 10. Thetriangular shape of the protrusions 32 further indicates the centerlineof travel of the razor blade 38. The protrusions 32 may similarly belocated on the opposite side of the cover 16. The casing 12 is alsoshown with a plurality of ridges 35 extending from the open end 18 ofthe casing 12. The ridges 35 may guide and align downward movement ofthe cover 16 along the casing 12. Cooperative structures along theinterior surface of the cover 16 may engage the ridges 35 to align thecasing 12.

FIGS. 3–5 show the interior structure and working components of thedevice 10 of the present invention in sequential order from apre-actuated position (FIG. 3), transition between positions (FIG. 4)and the post-actuated position (FIG. 5). Each of the FIGS. 3–5 show theblade 38, actuator 46 and carriage 58 of the present invention aspositioned within the casing 12. FIGS. 3–5 show views of the first panel9 of the casing 12, and FIG. 6 shows a view of the second panel 11 ofthe casing 12.

In particular, in the FIGS. 3–5, it can be seen that the casing 12 has aslot 36 formed on the bottom surface 14 thereof. A blade 38, indicatedin broken lines, is positioned in the interior 40 of the casing 12generally adjacent to the slot 36 and to the bottom surface 14. Thecasing 12 also has a side 20 extending upwardly from the bottom surface14 and another side 22 extending upwardly from the bottom surface 14. Abarb 26 is secured to the side 20 of casing 12. Another barb 42 issecured to the side 22 of casing 12. The cover 16 is shown in brokenlines.

As can also be seen in FIG. 1, the barb 26 engages the first retainingslot 28 on the wall 24 of cover 16. The barb 42 engages a correspondingfirst retaining slot 37 formed on the wall 34 of the cover 16. As aresult, the cover 16 will reside in its pre-actuated position.

In FIGS. 3–5, the casing 12 is presented with a release seat 13, a guidemember 15, and a capture seat 17 all made integral with an inner surfaceof the casing 12. The release seat 13 retains the knuckle 56 of theactuator 46 when the blade 38 is in the pre-actuated position (FIG. 3).The guide member 15 is illustrated as a generally L-shaped memberintegral with the capture seat 17. However, the guide member 15 isactually the end surface of this L-shaped member, along which thesurfaces of cam 64 contact. This end surface of guide member 15 slidablycontacts the cam 64 of the carriage 58 when the blade 38 moves from thepre-actuated position to the post-actuated position (FIG. 4). Thecapture seat 17 retains the knuckle 56 of the actuator 46 at thepost-actuated position (FIG. 5). The knuckle 56 of the actuator 46 isretained in the capture seat 17 so as to prevent re-setting the actuator46 for more than one use. The cooperation of the barb 26 and retainingslot 30 and the barb 42 and retaining slot 39 also serves to preventre-use. An alternative lock member may also be positioned within theinterior 40 of the casing 12.

FIGS. 3–5 also show the casing 12 with a support member 19 made integralwith an inner surface of the casing 12 and positioned adjacent the openend 18 of the casing 12. The support member 19 is in slidable contactwith the stem 41 of the actuator 46 within the casing 12 during thetransverse movement of the cover 16 when the blade 38 moves from thepre-actuated position to the post-actuated position. The support member19 is in the form of a pair of parallel blocks arranged in parallelspaced relation. The stem has a bulbous head 43 at an end thereof so asto prevent outward movement of the stem 41 from the support member 19.This arrangement facilitates the installation and assembly of theactuator 46 within the casing 12. In particular, the actuator 46 can beinstalled in a pre-actuated configuration by way of the retention of thestem 41 in the support member 19.

As shown in FIG. 6, the skin incision device 10 of the present inventionhas a casing 12 comprised of a first panel 9 (shown in FIGS. 3–5) and asecond panel 11 (FIG. 6) that are joined together. The second panel 11fixably connects to the first panel 9 and defines the slot 36 betweenthe first panel 9 and the second panel 11 at respective bottom surfaces14 thereof. The structures of the casing 12 can be positioned on eitherfirst panel 9 or second panel 11, including barbs 26 and 42 onrespective sides 20 and 22 thereof. The second panel 11 has pins 5 thatare received within pin holes 7 of the first panel 9 so as to secure thepanels 9 and 11 together and for a chamber or interior volume 40therein. FIG. 6 shows the blade 38 in broken lines in the second casing11 during horizontal movement from the pre-actuated position to thepost-actuated position corresponding to the view of the first casing 9in FIG. 4.

In FIGS. 3–5, it can also be seen that an actuator 46 has a top edge 48cooperative with an inner surface 63 of the cover 16. The top edge 48 isin abutment with the inner surface 63 of the cover 16 during movement ofthe blade 38 from the pre-actuated position (FIG. 3) to thepost-actuated position (FIG. 5). The actuator 46 has a resilient curvedmember 45 (in the form of a leaf spring) which will extend downwardly ina curved manner through the open end 18 of the casing 12. The terminalopposite end of the actuator 46 has knuckle 56 formed thereon. Theactuator 46 can be suitably changed, replaced, altered, or otherwisemanipulated so as to accommodate greater or lesser forces as requiredfor the skin incision process. Typically, the thickness of the resilientcurved member 45 and material selection of the actuator 46 will controlthe threshold amount of force to activate the blade 38.

The knuckle 56 is fixed by the casing 12 when the blade 38 is in thepre-actuated position at the release seat 13 shown in FIG. 3. Theresilient member 45 will bend outwardly so as to contact an upper edge47 of the release seat 13. This contact will cause the knuckle 56 topush upwardly and outwardly out of the notch 65 on the top surface ofthe release seat 13. The knuckle 56 contacts the blade 38 along edge 67during movement of the blade 38 from the pre-actuated position to thepost-actuated position shown in FIG. 4. Simultaneously and as shown inFIG. 6, there is a knuckle travel pocket 49 made integral with thesecond panel 11 of the casing 12. The knuckle travel pocket 49 guidesthe movement of the knuckle from the release seat 13 to the capture 17.The actuator 46 is prevented from interfering with other structureswithin the interior 40 by using the knuckle travel pocket 49 to stopextension of the knuckle 56 and resilient member 45 into the otherstructures in the casing 12, such as the cam 64. The casing 12eventually retains the knuckle 56 in the post-actuated position at thecapture seat 17 shown in FIG. 5.

The carriage 58 has a unique configuration within the casing 12. Inparticular, the carriage 58 has an anchored end 60 rotatably attached tothe casing 12, an arcuate member 62 extending from the anchored end 60,and a cam 64 positioned on a terminal end of the arcuate member 62. Thecam 64 is pivotally attached to the blade 38 at the pivot point 108 andguides the outward movement of the blade 38 from the slot 36 and fromthe pre-actuated position shown in FIG. 3. The cam 64 causes ahorizontal movement of the blade 38 after the outward movement byslidably contacting a surface 104 of the cam 64 against the bottomsurface of the guide member 15 of the casing 12, as shown in FIG. 4. Thecam 64 also guides an inward movement of the blade 38 toward the slot 36to the post-actuated position of FIG. 5. The arcuate member 62 may be aresilient member which springingly retracts the blade 38 verticallyinward of the slot 36. The cam 64 typically has a curved shape rotatablearound the pivot pin 108 attached to the blade 38.

FIG. 7 shows a partial enlarged perspective view of the cam 64 of thecarriage 58 of the skin incision device 10 of the present invention. Thecam 64 is shown with the pivot pin 108 on an end of the cam 64 which isrotatably attached to the retaining hole 78 of the blade 38. The cam 64has a flat back surface 106 which makes surface-to-surface contact withthe guide member 15 in the pre-actuated position, a curved upper surface104 corresponding to the travel path of the blade 38, and a flat forwardsurface 102 which pulls the cam 64 off the guide member 15 in thepost-actuated position. As a result, the cam 64 pulls the blade 38upward and prevents re-setting of the blade 38 in the pre-actuatedposition for more than one use. The flat forward surface 102 residesagainst the back of the guide member 15.

The blade 38 includes a razor member 76 having a cutting edge 77 formedat a lower end of the blade 38. Additionally, a retaining hole 78 ispositioned adjacent an opposite end of the blade 38 such that the pivotpin 108 extending from the cam 64 of the carriage 58 is cooperativelyreceived within the retaining hole 78. The carriage 58 pivotally guidesthe movement of the razor member 76 between the pre-actuated positionand the post-actuated position. The blade 38 further comprises anelongated hole 80 positioned between the retaining hole 78 and the razormember 76 of the blade 38. The elongated hole 80 is rotatably attachedto the casing 12 for anchoring the blade 38. The casing has a bladeretainer peg 82 formed therein adjacent the slot 36 of the casing 12.The elongated hole 80 of the blade 38 is positioned on the bladeretainer peg 82 such that the blade 38 is pivotally and slidablyanchored to the casing 12. The elongated hole 80 may be of an obroundshape in the blade 38 so as to be in generally pivotable and slidablerelationship one the blade retainer peg 82.

The blade 38 also has a first pivot point at the elongated hole 80,which is connected to the casing 12 and a second pivot point at theretaining hole 78 attached to the carriage 58. At the first pivot point,the blade 38 is in cam-relation to the casing 12 and rotatable on thecasing 12 during movement of the blade 38 from the pre-actuated positionto the post-actuated position. The first pivot point of the blade 38 canalso be an obround formed therein, the obround positioned over a bladeretainer peg of the casing 12.

FIGS. 3–5 show the device 10 with blade 38 movement between thepre-actuated position and the post-actuated position in sequentialorder. In particular, in FIG. 3, it can be seen that the cover 16 isbeen pressed downwardly upon the casing 12. The inner surface 63 of thecover 16 contacts the top edge 48 of the actuator 46. As a result, thebarbs 26 and 42 will be released from the respective first retainingslots 28 and 37 to be received within the respective second retainingslots 30 and 39 of the cover 16. The movable cover 16 travels in adownward motion and applies constant pressure against the skin duringthe actuation of the blade 38. The actuator 46 contacts the innersurface 63 of the cover 16 as it is actuated when a controlled loadlimit is achieved.

When a controlled load limit is achieved during the vertically downwardpressure of the cover 16, it can be seen in FIG. 4 and FIG. 6 that theresilient member 45 of the actuator 46 becomes suitably compressed bythe downward movement of the cover 16 relative to the bottom surface 14of casing 12. The resilient curved portion of the actuator 46 willbecome distorted or distended such that the knuckle 56 is freed from therelease seat 13 of the casing and is displaced horizontally from itspre-actuated position. FIG. 6 shows that the knuckle 56 upwardly pivotsby cantilever action of the resilient member 45 having a fulcrum pointat the upper edge 47 of the release seat 13. The actuator 46 has a leveraction with the knuckle 56 at the end of the resilient member 45. Thehorizontal motion of the knuckle 56 engages the contact surface 67 ofthe blade 38 at the pre-actuated position. As the knuckle 56 moveshorizontally in abutment to the contact surface 67 of the blade 38, themovement of the blade 38 is triggered from the pre-actuated position tothe post-actuated position. In FIG. 6, the knuckle travel pocket 49 ofthe release seat 13 is also in surface-to-surface contact with theknuckle 56 so as to guide the movement of the knuckle 56. The resilientmember 45 and the knuckle 56 are distended or distorted in a controlledpath to prevent interference with other interior structures in thecasing 12, such as the cam 64. The carriage 58 guides the blade 38during movement by the cam 64 pivotally attached to the blade 38.

The interaction of the cam 64 against the guide member 15 of the casing12 and the slidable contact by the elongated hole 80 of the blade 38with the blade retainer peg 82 of the casing 12 propels the razor member76 out of the casing 12, through the skin, and back into the casing 12in a very controlled action. This controlled action of the blade 38 issuch that the razor member 76 is slicing upon entry into the skin withthe blade retainer peg 82 at one end of the elongated hole 80 and withthe cam 64 at one end of its curved surface at the guide member 15 (FIG.3). Then, the blade 38 is guided horizontally while at a set depthmaintained by the blade retainer peg 82 sliding through to an oppositeend of the elongated hole 80 and with the curved surface of the cam 64and the guide 15 cooperatively maintaining the depth of the slice in thehorizontal direction (FIG. 4). The vertical slicing of the blade 38 uponexiting the skin is accomplished by the resilient spring action of thearcuate member 62 of the carriage 58 as the cam 64 is released from theguide member 15 of the casing 12. The post-actuated position results inthe blade retainer peg 82 being positioned in the original one end ofthe elongated hole 80 of the blade 38 (FIG. 5).

The controlled action of slicing, both entering and exiting, willminimize the trauma to the skin, will reduce the introduction ofundesirable elements of the skin tissue into the incision and bloodsample, and will promote the rapid healing of the incision location. Thepresent invention creates a patterned incision by the outward movementof the blade 38, horizontal movement and inward movement of the blade.The patterned incision secures a more standard sample for analysis,unlike the prior art devices which rely upon a puncture or stabbingmotion of the blade. Random tearing of the skin at the incision area andinconsistent depth of blade penetration are no longer factors whicheffect the sample analysis.

The operation of the present invention allows for a designed controlledforce to be achieved. The cover 16 will travel vertically over thecasing 12. The actuator 46 is restrained at one end by the supportmember 19 of the casing 12 and contacts the inner surface of cover 16.The opposite end of the actuator 46 is in contact with the release seat13 of the casing 12. The cover 16 will continue to travel downwardly andthe vertical application force is retained in the resilient curvedmember of the actuator 46 and converted to horizontal displacement ofthe knuckle 56. At a designed vertical pre-determined force, which isachieved as a function of distance traveled and resilient curved memberflexing, the actuator 46 makes contact with the blade 38. The verticalpre-actuation force is released in a horizontal motion, as shown inFIGS. 3–5. This release is controlled by the strength of the leafspring-like property of the resilient curved member 45.

The action described hereinbefore illustrates that a vertical force isappropriately transformed into a horizontal displacement on the interiorof the casing 12. The knuckle 56 of actuator 46 will begin to travel inabutment against the blade 38. As the knuckle 56 travels horizontallyagainst the blade 38, the movement of the blade 38 will be guided by thecarriage 58, which is pivotally attached to the blade 38. In thisencounter, the horizontal force will be converted to a outward verticalmovement of the blade, a horizontal movement of the blade and an inwardvertical movement of the blade. The interaction of the carriage 58,which is pivotally attached to the blade 38, with the guide member 15 ofthe casing 12 converts the horizontal force into the patterned movementof the blade 38. The curved surfaces of the cam 64 in cooperation withthe guide member 15 and the elongated hole 80 of the blade incooperation with the blade retainer peg 82 are uniquely designed toproduce the patterned incision. Once the cam 64 of the carriage 58begins to travel along its curve surface against the guide member 15,the blade 38 is forced to move vertically outward of the slot 36, thenhorizontally, and then vertically inward toward the slot 36 again. Theinward vertical movement is determined by the release of spring actionin the arcuate member of the carriage 58. A concurrent event also occursat the same time. As described in previously, the barbs 26 and 42 willnow engage the second retaining slots 30 and 39 on the walls 24 and 34of the cover 16. As a result, the cover 16 will be restrained in a fixedcondition which prohibits reuse of the device. Alternative lock membersmay also be positioned within the casing 12 so as to restrain theknuckle 56 in the capture seat 17 after use of the device.

The foregoing disclosure and description of the invention isillustrative and explanatory thereof. Various changes in the details ofthe illustrated construction can be made within the scope of the presentinvention without departing from the true spirit of the invention. Thepresent invention should only be limited by the following claims andtheir legal equivalents.

1. A skin incision device comprising: a casing having a slot formed at abottom surface thereof, said bottom surface suitable for placementagainst the skin; a cover positioned over said casing, said cover beingslidable in a direction transverse to a plane of said bottom surface ofsaid casing; a blade pivotally positioned within said casing generallyadjacent said slot, said blade having a pre-actuated position and apost-actuated position; an actuator means anchored to said casing, saidactuator means being actuatable by slidable movement of said covertoward said bottom surface, said actuator means for convertingtransverse movement of said cover into horizontal movement of saidactuator means, said actuator means engaging said blade at saidpre-actuated position through said post-actuated position such that atleast a portion of said blade extends outwardly of said slot during themovement between said pre-actuated position and said post-actuatedposition; and a carriage means anchored to said casing and pivotallyattached to said blade, said carriage means for guiding movement of saidblade from said pre-actuated position through said post-actuatedposition with a constant predetermined force of contact of said bottomsurface of said casing with the skin regardless of a force applied tosaid cover.
 2. The skin incision device of claim 1, said casing having agenerally open end opposite said bottom surface, said casing havingsides extending upwardly from said bottom surface.
 3. The skin incisiondevice of claim 2, at least one of said sides of said casing having abarb extending outwardly therefrom, said cover having a wall extendingover a portion of the side of said casing, said wall having a firstretaining slot formed therein and a second retaining slot formed thereinabove said first retaining slot, said barb engaging said first retainingslot when said blade is in said pre-actuated position, said barbengaging said second retaining slot when said blade is in post-actuatedposition.
 4. The skin incision device of claim 1, wherein said casing iscomprised of a release seat, a guide member, and a capture seat all madeintegral with an inner surface of said casing, said release seatretaining said actuator means when said blade is in said pre-actuatedposition, said guide member having a bottom edge slidably contactingsaid carriage means when said blade moves from said pre-actuatedposition to said post-actuated position, said capture seat receivingsaid actuator means at said post-actuated position.
 5. The skin incisiondevice of claim 1, wherein said casing comprises: a first panel; and asecond panel fixedly connected to said first panel, said first andsecond panels defining said slot.
 6. The skin incision device of claim1, said blade comprising: a razor member having a cutting edge; aretaining hole positioned adjacent an end of said blade, said carriagemeans being cooperatively connected to said retaining hole so as topivotally move said razor member between the pre-actuated position andthe post-actuated position; and an elongated hole positioned adjacent anopposite end of said blade, said elongated hole being rotatablyinterconnected to said casing.
 7. The skin incision device of claim 6,said casing having a blade retainer peg formed therein adjacent saidslot of said casing, said elongated hole of said blade positioned onsaid blade retainer peg.
 8. A skin incision device comprising: a casinghaving a slot formed at a bottom surface thereof, said casing having aretainer peg therein; a cover positioned on said casing, said coverbeing slidable in a direction transverse to a plane of said bottomsurface of said casing; a blade pivotally positioned within said casinggenerally adjacent said slot, said blade having a pre-actuated positionand a post-actuated position, said blade having a first pivot pointconnected to said casing, said first pivot point being an obroundpositioned over said retainer peg; an actuator means anchored to saidcasing, said actuator means being actuatable by slidable movement ofsaid cover toward said bottom surface, said actuator means forconverting transverse movement of said cover into horizontal movement ofsaid actuator means, said actuator means engaging said blade at saidpre-actuated position through said post-actuated position such that atleast a portion of said blade extends outwardly of said slot during themovement between said pre-actuated position and said post-actuatedposition, said blade having a second pivot point attached to saidcarriage means, said first pivot point being in rotatable and in camrelation to said casing during movement of said blade from saidpre-actuated position to said post-actuated position; and a carriagemeans anchored to said casing and pivotally attached to said blade, saidcarriage means for guiding movement of said blade from said pre-actuatedposition through said post-actuated position.
 9. A skin incision devicecomprising: a casing having a slot formed at a bottom surface thereof; acover positioned on said casing, said cover being slidable in adirection transverse to a plane of said bottom surface of said casing; ablade pivotally positioned within said casing generally adjacent saidslot, said blade having a pre-actuated position and a post-actuatedposition; an actuator means anchored to said casing, said actuator meansbeing actuatable by slidable movement of said cover toward said bottomsurface, said actuator means for converting transverse movement of saidcover into horizontal movement of said actuator means, said actuatormeans engaging said blade at said pre-actuated position through saidpost-actuated position such that at least a portion of said bladeextends outwardly of said slot during the movement between saidpre-actuated position and said post-actuated position a carriage meansanchored to said casing and pivotally attached to said blade, saidcarriage means for guiding movement of said blade from said pre-actuatedposition through said post-actuated position, said actuator meanscomprising: a top edge in abutment with an inner surface of said coverduring movement of said blade from said pre-actuated position to saidpost-actuated position; a resilient curved member extending downwardlyfrom said top edge; and a knuckle positioned on a terminal end of saidcurved member, said knuckle being fixed by said casing and spaced fromsaid blade when said blade is in said pre-actuated position, saidknuckle contacting in blade during movement of said blade from saidactuated position toward said post-actuated position.
 10. The skinincision device of claim 9, wherein said casing retains said knuckle insaid post-actuated position.
 11. The skin incision device of claim 9,wherein said casing is further comprised of a knuckle travel pocket madeintegral with an inner surface of said casing.
 12. The skin incisiondevice of claim 9, wherein said casing is comprised of a support membermade integral with an inner surface of said casing and positionedadjacent a top surface of said casing, said support member in slidablecontact with said actuator means within said casing during saidtransverse movement of said cover.
 13. A skin incision devicecomprising: a casing having a slot formed at a bottom surface thereof; acover positioned on said casing, said cover being slidable in adirection transverse to a plane of said bottom surface of said casing; ablade pivotally positioned within said casing generally adjacent saidslot, said blade having a pre-actuated position and a post-actuatedposition; an actuator means anchored to said casing, said actuator meansbeing actuatable by slidable movement of said cover toward said bottomsurface, said actuator means for converting transverse movement of saidcover into horizontal movement of said actuator means, said actuatormeans engaging said blade at said pre-actuated position through saidpost-actuated position such that at least a portion of said bladeextends outwardly of said slot during the movement between saidpre-actuated position and said post-actuated position; and a carriagemeans anchored to said casing and pivotally attached to said blade, saidcarriage means for guiding movement of said blade from said pre-actuatedposition through said post-actuated position, said carriage meanscomprising: an anchored end connected to said casing; an arcuate memberextending from said anchored end; and a cam means positioned on aterminal end of said arcuate member and pivotally attached to saidblade, said cam means for guiding outward movement of said blade throughsaid slot and for causing a horizontal movement of said blade after saidoutward movement and for guiding an inward movement through said slot.14. The skin incision device of claim 13, wherein said cam means has acurved shape rotatable around a pivot point attached to said blade. 15.A skin incision device comprising: a casing having a slot formed at abottom surface thereof; a cover positioned over said casing, said coverbeing slidable in a direction transverse to a plane of said bottomsurface of said casing; a blade pivotally positioned within said casinggenerally adjacent said slot, said blade having a pre-actuated positionand a post-actuated position; an actuator having an end cooperative withan inner surface of said cover and extending downwardly into saidcasing; and a carriage means positioned within said casing and pivotallyattached to said blade, said actuator cooperative with said blade fromsaid pre-actuated position to said post-actuated position, said carriagemeans moveable within said casing for guiding said blade between saidpre-actuated position and said post-actuated position, said actuatorbeing comprised of a resilient member having a knuckle formed at an endof said resilient member, said knuckle being spaced from said blade atsaid pre-actuated position, said knuckle contacting said blade duringmovement between said pre-actuated position toward said post-actuatedposition.
 16. The skin incision device of claim 15, said carriage meanscomprising: an arcuate member with an anchored end rotatably fastened tosaid casing; and a cam surface formed on a terminal end of said arcuatemember and pivotally attached to said blade, said cam surfacecooperative with said casing during an outward movement of said bladethrough said slot from said pre-actuated position and during ahorizontal movement of said blade after said outward movement and duringan inward movement through said slot to said post-actuated position. 17.The device of claim 15, said casing having a blade retainer peg formedtherein, said blade comprising: a razor member having a cutting edge; aretaining hole positioned adjacent an end of said blade, said carriagemeans being cooperatively connected to said retaining hole so as topivotally move said razor member between the pre-actuated position andthe post-actuated position; and an elongated hole positioned adjacent anopposite end of said blade, said elongated hole being rotatably mountedon said blade retainer peg of said casing.